FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 3070983
·
Received April 1, 2013
Report
- Report Number
- 3006451981-2013-00083
- Event Type
- Malfunction
- Date Received
- April 1, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 8, 2013
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING AN OOPHORECTOMY THE JAWS OF THE DEVICE COULD NOT BE RE-OPENED WHILE APPLIED TO TISSUE. IT IS UNKNOWN HOW THE DEVICE WAS REMOVED FROM THE TISSUE. THERE WAS NO INJURY TO THE PATIENT. THE CUSTOMER INDICATED THAT NO FURTHER INFORMATION WAS AVAILABLE REGARDING THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133124 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING DEVICE | GEI | COVIDIEN LLC (SHANGHAI) | S2G0037X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |